To compare the effectiveness of trans-cervical foley catheter and intravaginal Misoprostol in making the uterine cervix more favourable for induction of labour

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2008/002
• Date of registration: 28/03/2008
• Primary sponsor: Nil
• Public title: To compare the effectiveness of trans-cervical foley catheter and intravaginal Misoprostol in making the uterine cervix more favourable for induction of labour
• Scientific title: A randomised controlled trial comparing intra-vaginal Misoprostol with trans-cervical Foley catheter for the pre-induction cervical ripening
• Date of first enrolment: 1/1/2008
• Target sample size: 50 subjects for each arm
• Recruitment status: Suspended
• URL: http://www.slctr.lk/trial_details.asp?reg_id={EB2C6A27-0589-4E26-9D2A-DAA1E208EC03}
• Study type: Interventional
• Study design: A randomised controlled trial

Countries of recruitment

Sri Lanka

Contacts

• Name: Dr. T.D. Dias
• Affiliation: Senior Registrar

• Name: Dr. K.M.D.J. Rodrigo
• Affiliation: Research Associate

Key inclusion & exclusion criteria

Inclusion criteria: Consented women with singleton gestation in vertex presentation at greater than 28 weeks gestation with Bishop’s score less than 6
Exclusion criteria: •Rupture of membranes antepartum bleeding
•active genital herpes infection
•fetal death
•placenta praevia
•previous induction or pre-induction agent during the pregnancy, and known allergy to misoprostol
•Women with history of cesarean deliveries will not be excluded

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Effectiveness of trans-cervical foley catheter and intra-vaginal Misoprotol for pre induction cervical ripening

Intervention(s)

A patient who will be decided to undergo labour and who meet the criteria for the study will be randomized to receive either trans-cervical foley catheters or intra-vaginal misoprostol as the pre- induction cervical ripening agent.

Primary Outcome(s)

•Time to vaginal delivery or vaginal delivery rates within a specified time Operative delivery rates (caesarean section and instrumental vaginal delivery)
•Length of labour/incidence of prolonged labour
•Measures of effectiveness (oxytocin augmentation rates
•epidural usage
•cervix unfavorable/unchanged at 12–24 hours)
•Serious maternal morbidity or death
•Other adverse outcomes (e.g. uterine hypercontractility
•Postpartum haemorrhage
•Maternal adverse effects)
•Measures of maternal satisfaction
•Serious neonatal morbidity or perinatal death
•Other adverse perinatal outcomes (meconium-stained liquor
•Five-minute apgar score of less than seven
•Neonatal intensive care unit admission)

Secondary ID(s)

None

Source(s) of Monetary Support

Nil